[M14-682] Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves through the Body of Pediatric and Adolescent Participants with Active Systemic Juvenile Idiopathic Arthritis.
- Conditions
- Juvenile Idiopathic Arthritis
- Registration Number
- jRCT2031230402
- Lead Sponsor
- AbbVie G.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
- Baseline with a total body weight of 10 kg or higher at screening and a diagnosis of systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) criteria for at least 6 weeks prior to Screening, with onset prior to 16 years old, and meet the following conditions: -- Must have active sJIA with at least 2 active joints at Screening and Baseline, fever more than 38 Celsius for any out of 14 consecutive days before the Screening Visit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP) > 1.5 x upper limit of normal (ULN) at Screening. OR At least 5 active joints at Screening and Baseline and an ESR or hsCRP > 1.5 x ULN at Screening. -- Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and systemic glucocorticoids, as judged by the investigator. -- For Cohort 1, participants must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, participants must have an intolerance or inadequate response to an IL-6 inhibitor as judged by the investigator. Note: For Cohort 1, participants must be ages 2 to < 18 years old in countries where subcutaneous tocilizumab is not approved for sJIA.
- Must have any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined by the ILAR criteria, and must not have a history or presence of any other autoimmune inflammatory condition other than sJIA.
- Must have uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 3 months prior to Baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response Percentage of participants achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response Percentage of participants achieving adapted sJIA ACR 50 response
Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP Percentage of participants achieving clinical remission by JADAS27-CRP
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response Percentage of participants achieving adapted sJIA ACR 70 response
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response Percentage of participants achieving adapted sJIA ACR 90 response
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response Percentage of participants achieving adapted sJIA ACR 100 response
Change from Baseline in Number of Joints with Active Arthritis Change from baseline in number of joints with active arthritis
Change from Baseline in Number of Joints with Limitation of Motion Change from baseline in number of joints with limitation of motion
Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Change from baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI)
Change From Baseline in Patient's Global Assessment (PtGA) Change from baseline in Patient's Global Assessment (PtGA)
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA) Change from baseline in Physician's Global Assessment of Disease Activity (PhGA)
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Change from baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Percentage of Participants with Absence of fever (> 38 Celsius) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA) Percentage of participants with absence of fever (> 38 Celsius) attributed to sJIA
Change from Baseline in Glucocorticoid Dose Change from baseline in glucocorticoid dose
Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP Percentage of participants achieving inactive disease (ID) status by JADAS27-CRP
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP) Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)
Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP Percentage of participants achieving minimal disease activity (MDA) by JADAS27-CRP